JP4082952B2

JP4082952B2 - Medical treatment tool

Info

Publication number: JP4082952B2
Application number: JP2002211976A
Authority: JP
Inventors: 清貴有川; 稔柴田
Original assignee: Sumitomo Bakelite Co Ltd
Current assignee: Sumitomo Bakelite Co Ltd
Priority date: 2001-11-02
Filing date: 2002-07-22
Publication date: 2008-04-30
Anticipated expiration: 2022-07-22
Also published as: JP2003199748A

Description

【０００１】
【発明の属する技術分野】
本発明は切開創を開創する医療処置用具に関する。特に内視鏡下外科手術において、気腹下での処置の後、気腹を解除して体外に臓器を取り出して処置を行ったり、再び臓器を体内に戻して再気腹下の操作で患部の確認や追加処置を行うための医療用処置用具に関するものである。
【０００２】
【従来の技術】
近年、低侵襲外科手術の方法として内視鏡外科手術が広く実施されている。内視鏡外科手術は低侵襲であり、入院期間が短く、外傷も小さくて済む等の利点がある。一方で術者には、内視鏡で映し出された映像を画面で見ながら複数の鉗子等の処置具を操作して手術を行う為、操作が難しく時間が長くかかりストレスを多く感じる難点がある。特に胃や大腸の手術は長時間になることが多く、術者は大きなストレスを受ける。このため、内視鏡下の処置後に最終的に大きな標本の摘出が想定される場合、小切開をおくことを前提として、気腹下での処置と小切開部から体表に臓器を引き出して行う処置とを簡単に移行できるように小切開口を簡単に塞ぐことができる医療用処置用具が要求されている。
【０００３】
特開平１１−１６０９４２号公報では、腹壁を挟んで固定する部材と円筒状部材からなる装置で、腹壁を挟む部材の間隔を腹腔内に挿入した固定部材に予め固定した糸等で引っ張り上げて腹腔外の固定部材に留め調節するシンプルな機構で、更に処置具の非挿入時および挿入時の気密性を保つための２種の気密部材により、再気腹時に小切開口部より鉗子類の挿入・操作が可能な医療用処置具を開示している。
この装置を使用することにより、気腹下で摘出臓器周囲の剥離などの処置を十分に行った後、臓器を取出す場所に３〜５ｃｍ程度の小切開をおき、その小切開口から対象臓器を体外に取りだして病変部の切離、摘出、縫合を術者が直接見て、手術を行うことができる。しかしながら、「糸で切開部を開創すると切開部の腹壁に糸がめり込み十分な開創が困難である。」「固定部材間隔調整用シートを固定する突起が付設されている他、概シートが開創部の周りに付設されており、臓器を引き出しての処置が困難になる」等の問題点があった。
【０００４】
特開平１０−１０８８６８号公報では使用する鉗子類の種類を選ばず腹腔内から気腹ガスがリークするのを防止することが可能な弁及び弁付トラカール外套管が開示されている。この弁は２枚のリングの間に柔軟な円筒状部材を付設し、２枚のリングを逆方向に捻ることで外径の異なった鉗子や術者の腕を挿入し、体内の処置を行うことが可能であり、この弁を開くことで臓器を体外に取りだして処置を行うことも可能である。しかしながら、この方式では鉗子等が弁によって絞られながら固定されるため、前進後退がしにくい欠点がある。また、腕を挿入した場合は特に前後運動によって腕の太さが変わるため場合により気密が保持しにくくなり、弁の絞りを調節する必要がある。さらに腹壁へのデバイスの固定力が円筒状部材のゴム弾性のみに頼っているため腹壁の厚さに柔軟に対応できず十分な創部の開創が得られない問題点があった。
【０００５】
ＵＳＰ５４８０４１０号では柔軟で内面と開口端があるエンクロージャーで、開口端には腹壁固定及び気密を守るための展開手段を持ち、エンクロージャーの内部にアクセスするための少なくとも一つのアクセスオープニングがあり、腹腔内あるいはエンクロージャーの内部で外科手術を行うことが可能である装置が開示されている。この装置は従来、腹腔鏡、胸腔鏡手術に使用されているような硬性のトラカールではなく、柔軟なシート材で構成されており、腹壁の切開口にあった形状に変形可能な展開手段を切開口から挿入して腹腔内で展開させ、気腹用の炭酸ガスが腹腔内からエンクロージャー内部へ流入してエンクロージャーが膨脹し、展開手段は腹壁との気密を守る。更にエンクロージャー外周表面にアクセスオープニングを複数取り付ければ複数の鉗子が挿入でき、創部直下の観察も可能であり、創縁も保護される。しかしながら、エンクロージャーは基本的に球状であり、外周表面に取り付けられた各々のアクセスオープニングまでの距離は、設定時に決定され固定されてしまうため、複数の処置具を挿入している際、１本の処置具を大きく動かすと他の処置具も引きずられて動いてしまったり、また、腹壁の切開口が鉗子などの処置具に対して大きく操作時の腹壁での支点がないため鉗子操作が煩雑になる他、創部の開創がシートの伸張力にのみ頼っているため、腹壁の厚さによっては十分な開創が得られない問題点があった。
【０００６】
ＵＳＰ５６４０９７７号では、アウタースリーブと２つのシール手段を持つ構造で、小切開口を通して腹腔内に入り、２つのシール手段を使ってアウタースリーブ内に気密な空間を構成する装置が開示されている。この装置は装置内を通して体内に術者の手及び腕を挿入した際、気腹をした状態で体内臓器の処置を行うことができ、また、第三のシール手段を使えば、腕を抜いた状態でもスリーブ及び体内の気密を保つことができる。しかしながら、この装置は術者が体内の臓器を体外に引き出して処置したい際、スリーブ部分を患者の体表に被せてあるドレープに接着する構造であり、接着部より上側を分離できる状態になっていないため、ドレープを切り取り装置全体を一旦取り出すか、スリーブ部分を切り取らないと体外に臓器を取り出して処置することができない。装置を取り出せば腹壁に癌組織等が付着する恐れがあり、また、スリーブ部分を切り取れば、体外での処置が終わった後で再度気腹を行い腹腔内で観察、処置することができない。
【０００７】
ＵＳＰ５８１３４０９号では、スリーブと腹壁固定部を分離し、スリーブの遠位端のリングと、腹壁固定部のリングをスナップして固定する装置等が開示されている。この装置はスリーブと腹壁固定部を分離できるため、スリーブ部分を取り外して、腹壁固定部を腹壁に残したまま体内の臓器を体外に引き出して処置でき、切開口に癌組織が付着することもなく、処置が終わった後、臓器を体内に戻して再度スリーブを固定して気腹下で観察、処置を行うことができる。しかし、スリーブと腹壁固定具のリングをスナップで全周にわたってはめ合わせることは難しく、はめ合わせの不十分な箇所があった場合は、気密を保持できなくなる。また、もし、スリーブを通して処置具を操作すると、この装置も腹壁の切開口が鉗子などの処置具に対して大きく、操作時の腹壁での支点がないため鉗子操作が煩雑になるという欠点があった。
【０００８】
ＵＳＰ５３６６４７８号や特表２０００−５０１９７８では体内外にわたって一繋がりのドーナツ型のバルーンを膨脹させることで内腔を閉じて手や鉗子挿入時および抜去時の腹腔内の気密を保つ装置が開示されている。この装置は構造が単純で組み立ても簡単であるので手術時間を短縮できる。しかしながら、ＵＳＰ５３６６４７８号の装置では気腹を解除して体外に臓器を取り出して処置を行いたい場合、バルーンを収縮させなければならず、同時に創部が閉じてしまうために新たに開創器具を用いなければならないという欠点があった。また、両者共にバルーンが円周方向に膨張する為、デバイスの体表からの高さが高くなり、臓器を十分体外に引き出しにくい他、処置する部位に鉗子等を位置させにくくなる問題点があった。
【０００９】
特開平１１−９９１５６号公報では、スリーブを腹壁の上下からリング状部材で固定し、通常のシール弁と弾性薄膜でつくったスリット状の開口を有する弁の２つの弁を有することで、手の挿入時および非挿入時の気密性を高めた装置が開示されている。この装置は手および鉗子の非挿入時にスリット状の弁が腹腔圧によって折り返し部分からなる接触面が互いに押し付けられるように膨脹することにより気密を保持するため、手の挿入時に弁を開いてしまえば弾性薄膜の弾性力以上の力は発生しないため、腕を締め付ける力は非常に小さくて済み、長時間の使用において術者のストレスが軽減される。しかし、この装置では気腹を解除して体外に臓器を取り出して処置を行いたい場合や創部から直視下で処置を行いたい場合に、特にスリット状の弁がじゃまになってしまう欠点があり、また、スリーブを通して処置具を操作するとこの装置も腹壁の切開口が鉗子などの処置具に対して大きく、また、操作時の腹壁での支点がないため鉗子操作が煩雑になるという欠点があった。
【００１０】
ＵＳＰ５７４１２９８号では、腹壁の切開口周辺部の外側と内側からしっかり挟んで固定されるポートと、そのポートに取り付ける蓋により内腔を閉じて手や鉗子挿入時および抜去時の腹腔内の気密を保つ装置が開示されている。この装置は構造が単純で組み立ても簡単であるので手術時間を短縮できる。しかし、この装置では切開口の大きさや腹壁の厚さに柔軟に対応できず、十分な創部の開創を得られないという欠点があった。
【００１１】
ＵＳＰ５６５３７０５号ではネジ山の付いたテーパー形状の環状部材を腹壁にねじ込んで固定し、着脱可能な可とう性のエンベロープを取り付け、手や鉗子挿入時および抜去時の腹腔内の気密を保つ装置が開示されている。この装置は環状部材を創部にねじ込むだけで容易に腹腔内へのアクセスポートを設置でき、環状部材が鉗子の支点となりうるため鉗子操作が容易に行える。しかしながら、環状部材を創部にねじ込んで用いるために創部を痛める恐れがある他、ねじ込みやすい角度をつける為には、環状部材が嵩高くなってしまう問題点や、腹壁の厚さと切開口の大きさに対して柔軟に対応できないという欠点があった。
【００１２】
【発明が解決しようとする課題】
本発明は、従来の内視鏡下手術における処置のこのような欠点を解決するもので、その目的とするところは、様々な腹壁の厚さや切開創の大きさに柔軟に対応した設置が可能で、切開創周りでの処置が簡便となるように、設置後の二次的な開創操作が可能で、設置時の器具の体表から高さが低く、簡単に気腹下処置と腹腔外処置との切り替えができ、気腹下での処置を行う場合には鉗子操作が行える医療用処置用具を提供することにある。
【００１３】
【課題を解決するための手段】
すなわち本発明は、
（１）筒状部材の近位端側の開口部には第一の固定部材を付設し、遠位端側の開口部には第二の固定部材を付設した切開創に留置する医療用処置具において、
前記第二の固定部材には両固定部材間の長さを調整する２つ以上の引張りベルトが付設され、前記第一の固定部材の体表接地面に対して垂直な側面には前記引張りベルトを気密に係止めする手段を有するベルト抵抗調整部材が付設され、前記引張りベルトは、前記第一の固定部材の前記側面および前記ベルト抵抗調整部材を水平方向に貫通して配置され、前記第一の固定部材上に設置され、前記第一の固定部材の外縁に対し、その外縁が係合し、前記第一の固定部材に気密に固定されるコンバーターを有する医療用処置用具、
（２）前記引張りベルトを気密に係止めする手段が、前記ベルト抵抗調整部材の前記引張りベルトを通すスリット付近に形成された凹凸であり、前記引張りベルトには、前記凹凸に対応し、前記凹凸に係止されるラチェット溝が形成されている（１）記載の医療用処置用具、
（３）前記ベルト抵抗調整部材の前記凹凸がノコギリ歯形状である（２）記載の医療用処置用具、
（４）前記ベルト抵抗調整部材の前記凹凸と、前記引張りベルトの前記ラチェット溝との係止めを解除する手段を有している（２）または（３）記載の医療用処置用具、
（５）前記係止めを解除する手段が前記引張りベルトの前記ラチェット溝と前記ベルト抵抗調整部材の前記凹凸の間に挿入される薄板である（４）記載の医療用処置用具、
（６）係止めを解除する手段が前記ベルト抵抗調整部材の前記凹凸に接続され、前記ベルト抵抗調整部材から突出する突起部である（４）記載の医療用処置用具、
（７）前記ベルト抵抗調整部材、前記引張りベルトの両方又は片方の少なくとも一部分が、縦弾性率０．０５〜１０ｋｇ／ｍｍ²の材料で構成される（１）〜（６）いずれか記載の医療用処置用具、である。
【００１４】
【発明の実施の形態】
本発明の医療用処置用具を図で説明する。図１に全体の外観を示す。本発明の医療用処置用具は次の部品で構成されている。それは第一の固定部材（１）、第二の固定部材（２）、引張りベルト（３）、ベルト抵抗調整部材（４）、筒状部材（５）、コンバーター（６）及び気密部材（７）である。
【００１５】
（医療用処置具の構造）
構造を簡単に説明すると第二の固定部材（２）は臓器取り出し用の開口部（１２）を持ち、筒状部材（５）の開口部（１２）に沿って固定される。筒状部材（５）のもう一端は第一の固定部材（１）に接続される。第二の固定部材（２）には任意の数の引張りベルト（３）を付設する。引張りベルト（３）はベルト抵抗調整部材（４）のスリット（１８）を通し配置する。ベルト抵抗調整部材（４）は、第一の固定部材（１）に配置される。第一の固定部材（１）には、気腹ガスの漏れを防ぐコンバーター（６）が付設される。コンバーター（６）には気密部材（７）がほぼ中央に付設される。筒状部材（５）と引張りベルト（３）は腹壁の厚さよりも長く、任意の腹壁の厚さにも設置することが可能であり、引張りベルト（３）に張力を与えることで切開創の開創が可能である。コンバーター（６）は第一の固定部材（１）に簡便に取り付けることが可能であるため、気腹操作と臓器を取り出しての操作の移行が簡便である。コンバーター（６）には気密部材（７）が付設されているため、トロッカー等を設置することができ、鉗子等を用いた処置が可能である。
【００１６】
（第一の固定部材）
第一の固定部材（１）は筒状部材（５）の開口部（１２）に沿って付設される。通常、射出成形、圧縮成形によって作製される。筒状部材（５）表面に密着して熱溶着または接着固定されるか、Oリング等を使用して物理的な締め付けにより固定される。形状は円形や多角形等で中央に臓器取り出し用の開口部（１２）を持つ形状で特には限定しないが、開口部（１２）に術者の握りこぶしが挿入可能で、腹上に設置した場合に嵩張らない程度の大きさが望ましく、外寸が直径５０〜３００mmの大きさ、内寸が直径３０〜２８０ｍｍのリング形状がよい。第一の固定部材（１）の高さはできるだけ低い方が、第一の固定部材（１）の開口部（１２）から臓器を体表に引き出し易くなる他、開口部（１２）を支点として柄の長い処置具を体内に挿入する場合に処置範囲が広くなり好ましく、５〜５０ｍｍであることが好ましい。
【００１７】
第一の固定部材（１）にはベルト抵抗調整部材（４）を配置する。ベルト抵抗調整部材（４）は第一の固定部材（１）の体表接地面（１３）もしくはその反対側から掘り下げた溝に配置しても良いが、図１（Ｃ）に示すように第一の固定部材（１）の体表接地面（１３）に対して垂直な側面に空隙を設置し、この空隙にベルト調整部材（４）を配置する方が、コンバーター（６）の設置面を一つの部材で継ぎ目なくすることができ、気密性を確保することが容易となり望ましい。また、ベルト抵抗調整部材（４）を固定する部位にリブを設置する方が気密性が向上し望ましい。
【００１８】
引張りベルト（３）が臓器を引き出しての処置に支障がないように、第一の固定部材（１）には引張りベルト（３）を水平方向に引張るような構造となるようにベルト抵抗調整部材（４）を付設することが望ましい。第一の固定部材（１）にはコンバーター（６）が嵌合される。コンバーター（６）が嵌合しやすいように、第一の固定部材（１）の外縁はコンバーター（６）の爪が引っかかる形状とすることが望ましい。第一の固定部材（１）の上部は引き出した臓器が直接接触するため、傷つけぬよう平坦であることが望ましい。第一の固定部材（１）の材質は塩化ビニル樹脂、ポリウレタン樹脂、ポリアミド樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂、ＡＢＳ樹脂、ＳＥＢＳ樹脂、シリコーンゴム等や、ステンレス鋼等の金属が使用される。
【００１９】
（第二の固定部材）
第二の固定部材（２）は筒状部材（５）の開口部に沿って付設される。通常、射出成形、圧縮成形または押出成形チューブの加工によって作製される。筒状部材（５）に包まれ、密着して熱溶着または接着固定されるか、第二の固定部材（２）表面に密着して熱溶着または接着固定される。或いはOリング等を使用して物理的な締め付けにより固定されてもよい。腹腔鏡補助下大腸切除術を行う場合、約２０〜８０ｍｍの小切開に対して内径約３０〜１２０ｍｍ、外径約４０〜２００ｍｍに設定することが好ましい。厚さは腹腔内で嵩張らないことが要求されるため、０．５〜１０ｍｍ程度が好ましい。切開創から腹腔内に第二の固定部材（２）を折り曲げて挿入するため、素材はある程度の弾力を備えている方が好ましい。第二の固定部材（２）の材質は塩化ビニル樹脂、ポリウレタン樹脂、ポリアミド樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂、ＡＢＳ樹脂、ＳＥＢＳ樹脂、シリコーンゴム等や、ステンレス鋼等の金属が使用される。
【００２０】
（引張りベルト）
引張りベルト（３）は第二の固定部材（２）に接続され、ベルト抵抗調整部材（４）のスリット（１８）を通すように配置する。引張りベルト（３）の幅は、図２に示すがごとく切開創を大きく（なるべく円形に）開創するために１０ｍｍ以上であることが望ましいが、過度に幅広いと切開創へ挿入し難くなるため、１０〜６０ｍｍの範囲であることが好ましい。厚さは体表での用具の高さを低く抑えるために０．１〜５ｍｍのシート状であることが好ましい。引張りベルト（３）の長さは種々な腹壁に対応するために長い方が良いが、長すぎると開創した際に体表に露出し、トロッカー等の穿刺部位を制限するため、実用的な長さとして３０〜２００ｍｍとすることが好ましい。
【００２１】
切開創を開創した場合に開創した大きさが収縮しない様に引張りベルト（３）には図３に示すようなノコギリ歯状のラチェット溝（１７）が付設されることが望ましい。ラチェット溝（１７）の深さは厚みを薄く保つために、０．５〜２．５ｍｍ程度に設計することが好ましい。ラチェット溝（１７）は図３（Ｂ）、（Ｃ）に示すように一部に付設しても良い。図４に示すようにラチェット溝（１７）の角度Ａを鋭角的な形状とすると開創時の抵抗を減少し好ましい。引張りベルト（３）に付設するラチェット溝（１７）は側面に付設しても良いが、図１に示すように開口部（１２）と反対側に作製した方が臓器を引き出す際にベルトのラチェット溝（１７）に接触しないため、臓器を傷つける恐れがなく好ましい。
【００２２】
材質は適度な柔軟性があり、滑りがよい材料がよい。円滑な操作を行うには引張りベルト（３）は全体又は凹凸などその一部を変形するように適度な硬さ（ショア硬度Ａ４０〜Ｄ６０程度の材料）が好ましい。不織布、もしくは織物のシート材料あるいは、押出成形、射出成形、圧縮成形等により作製されるが、特には限定されない。ポリアミド樹脂、塩化ビニル樹脂、ポリウレタン樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂等が使用できる。樹脂又は金属メッシュの入りのシートも変形が少なく好ましい。
【００２３】
（ベルト抵抗調整部材）
ベルト抵抗調整部材（４）は第一の固定部材（１）に付設される。ベルト抵抗調整部材（４）は引張りベルト（３）を通すスリット（１８）が付設されている。スリット（１８）は気密性を確保する為に、引張りベルトの断面とほぼ同じ形状とした方が好ましい。このスリットの周辺には引張りベルト（３）のラチェット溝（１７）と対応する凹凸（１９）が付設され、引張りベルト（３）に係り止めし、開創状態が収縮することを抑制する。ベルト抵抗調整部材（４）は、第一の固定部材（１）に配置するときに気密を保つようにリブ（１４）または凹部を付設することが望ましい。一例を図５に示す。
【００２４】
ベルト抵抗調整部材（４）は、開創状態と収縮状態を臨機応変に切り替えられるように、引張りベルト（３）の係止め状態を解除できる手段を備えている方が望ましい。例えば図６示すように、薄板（２０）を引張りベルト（３）とベルト抵抗調整部材（４）の凹凸（１９）の間に挿入することで凹凸（１９）の係止めを解除することができる。薄板（２０）は別の部材として備えても良いし、薄板（２０）を第一の固定部材（１）にスライド可能に固定しても良い。
【００２５】
また、図７、図８のように、ベルト抵抗調整部材（４）の凹凸を係止め状態から解除できる方向に移動できるように、凹凸（１９）から延長した突起部（２１）を付設し、これを操作して凹凸（１９）を移動させても良い。図７に示すように、ベルト抵抗調整部材（４）は、凹凸（１９）を確実に移動させることができるように、凹凸（１９）の両端の近くに切り欠き部（２２）を付設することが望ましい。図８は二部品からなり、凹凸（１９）を含む部品の突起部（２１）を引張ると残りの部品に付設されたガイドに従って、下側に移動する構造となっている。下側に凹凸（１９）を含む部品が移動することにより、係止め状態が解除される。
【００２６】
図９に示すようにベルト抵抗調整部材（４）を二部品（４Ａ、４Ｂ）に分割し、凹凸（１９）を含む部品（４Ｂ）の下側にバネを付設し、凹凸（１９）を上下に移動可能としても良い。また、図１０に示すように、ベルト抵抗調整部材（４）を二部品（４Ａ、４Ｂ）とし、凹凸（１９）を水平方向に引き抜ける構造としても良い。図１１に示すようにベルト抵抗調整部材（４）を三つの部品に分割し、凹凸操作部分（２４）により凹凸（１９）を開いて移動させてもよい。またベルト抵抗調整部材（４）の内部を空洞にして圧力を減少させて係止めを解除しても良い。
【００２７】
ベルト抵抗調整部材（４）には切開層の開創程度の縮小を抑制するように凹凸（１９）が付設されている為、開創操作時には抵抗が生じる。円滑な操作を行うにはベルト抵抗調整部材（４）は全体又は凹凸（１９）などその一部を変形するように適度な硬さ（ショア硬度Ａ４０〜Ｄ６０程度の材料）が望ましい。材質としては塩化ビニル樹脂、ポリウレタン樹脂、ポリアミド樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂、ＡＢＳ樹脂、ＳＥＢＳ樹脂、シリコーンゴム、が使用される。
【００２８】
（筒状部材）
筒状部材（５）は肉厚０．０５〜３ｍｍの平面またはテーパーのかかった筒状であり、通常、押出成形またはインフレーション成形等により作製されるが特に限定されない。筒状部材（５）の大きさは処置を行う部位、目的によって異なるが、腹腔鏡補助下大腸切除術に使用される場合、外径が３０〜３００ｍｍが望ましい。使用時には内視鏡や鉗子等の処置具が頻繁に出入りするため、嵩張らず、適度に柔軟で、更に、処置具等が当たっても切れたり裂けたりし難い材質を選ぶのが良く、例えば、軟質塩化ビニル樹脂、ポリウレタン樹脂、ポリエチレン樹脂、ポリアミド樹脂、ポリプロピレン樹脂、ポリエステル樹脂、ＳＥＢＳ樹脂、シリコーンゴム、天然ゴム等の材質が好ましい。
【００２９】
（コンバーター）
コンバーター（６）は第一の固定部材（１）上に設置し、気腹時に腹腔内の気密を確保するためのものである。着脱を行う場合、第一の固定部材（１）との凹凸やネジによって固定しても良いが、コンバーター（６）の端にツメ（１１）を付設し、第一の固定部材（１）の側面に嵌合する様式をとった方が簡便で好ましい。通常射出成形、圧縮成形などで成形される。コンバーター（６）は図１（Ｂ）、図１２のように開口部のない気密部材（７）を取り付け、これを刺入して用いるタイプや図１３のように第一の気密部材（８）と第二の気密部材（９）を付設したタイプ、図１４のように第一の気密部材（８）と第二の気密部材（９）を一体成形したタイプが考えられる。コンバーター（６）には気密部材（７）が付設され、その中央に窓（１０）を形成する。窓（１０）の大きさは挿入する処置具等の大きさによって決められ直径１〜２５０ｍｍ、好ましくは直径１〜１５０ｍｍに設定することが適当である。高さは処置の際に邪魔にならないように１〜４０ｍｍが適当である。その材質は塩化ビニル樹脂、ポリウレタン樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂、ポリカーボネート樹脂、ポリサルフォン樹脂等の硬質樹脂かシリコーンゴム、天然ゴム、ＮＢＲ等の合成ゴムが使用される。
【００３０】
（気密部材）
気密部材（７）は図１２のようにトロッカーや鉗子挿入時に気密を保つために配置される。開口部のない隔膜である。厚さは０．１〜３ｍｍが好ましい。これは、０．１ｍｍ未満では炭酸ガスの圧力により弁が変形され易くなり、３ｍｍを超えると鉗子等の処置具を挿入する際の摩擦抵抗が大きくなり、挿入が困難となるためである。内径は処置具等の外径に合わせ、０．５ｍｍ〜８０ｍｍが好ましい。トロッカー等の処置具を挿入した際に気密が保てるように、気密部材の材質は引き裂き強度が５〜１００Ｎ／ｍｍであることが好ましい。更に、可とう性を有するものがより好ましく例えば天然ゴム、シリコーンゴム、塩化ビニル樹脂、ウレタン樹脂、ＳＥＢＳ樹脂等が好適である。
【００３１】
（第一の気密部材）
第一の気密部材（８）は鉗子等を挿入していない時に気密を保つために設置するものであり、近位端の先端をキャップ等で閉じたり、図１３のように、内部にフラップタイプの弁やダックビルタイプの弁等の弁部材を付設しても良い。また、単にシートにスリット加えた図１４のようなタイプでも良い。スリットの長さは挿入するトロッカー、処置具、又は腕のサイズにあわせて設定すればよく、１〜２５０ｍｍ、特に１〜１５０ｍｍが好ましい。図１４のように一体成形をする場合はスリットが裂けた場合でも第二の気密部材まで引き裂けないように肉厚部を設置したりすることが望ましい。キャップ等で閉じる場合は近位端入口に嵌合部材を取り付け、それとの凹凸で嵌合させたり、ネジによって固定しても良い。キャップは通常射出成形などで成形され、その材質は塩化ビニル樹脂、ポリウレタン樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂、ポリカーボネート樹脂、ポリサルフォン樹脂など若干硬質の樹脂かシリコーンゴム、天然ゴム、ＮＢＲ等の合成ゴムなどが使用される。フラップタイプの弁は通常、腹腔鏡外科手術等で使用されるトロッカーに内蔵されているような硬質の成型品とバネ部材を組み合わせた物でも、シリコーンゴムのような弾性部材をフラップ形状に成形、加工して使用しても良い。フラップタイプの弁は体外側に開くことはなく、体内側にのみに動くので、処置具等が挿入されていない時は体内側の陽圧によりフラップが体外方向に押されて閉じる構造である。フラップタイプの弁は射出成形や圧縮成形などで成形され、その材質は塩化ビニル樹脂、ポリウレタン樹脂、ポリエチレン樹脂、ポリプロピレン樹脂、ポリアセタール樹脂、ポリカーボネート樹脂、ポリサルフォン樹脂、シリコーンゴム等が使用される。ダックビルタイプの弁も同様に射出成形や圧縮成形で成形され、主としてシリコーンゴム等の弾性材料で作製される。
【００３２】
（第二の気密部材）
第二の気密部材（９）は鉗子等を挿入している際に気密を保つために配置され、円形の穴の開いたシール弁等を付設しても良い。シール弁は射出成形、圧縮成形、シート加工等により作製され、近位端入口やコンバーター（６）に熱溶着または接着される。シール弁の厚さは０．１〜３ｍｍ程度が好ましい。これは、０．１ｍｍ未満では炭酸ガスの圧力により弁が変形され易くなり、３ｍｍを超えると鉗子等の処置具を挿入する際の摩擦抵抗が大きくなり、挿入が困難となるためである。内径は処置具等の外径に合わせ、０．５ｍｍ〜３０ｍｍが適当である。シール弁の材質は、可とう性を有するものが好ましく例えば天然ゴム、シリコーンゴム、塩化ビニル樹脂、ウレタン樹脂、ＳＥＢＳ樹脂等が好適である。
【００３３】
(使用方法)
次に本発明による医療用処置用具の実際の使用方法について説明する。腹腔鏡補助下大腸切除術を行う場合、まず、複数本のトロッカーを腹部に挿入し、臓器摘出予想部位に約３〜５ｃｍ程度の小切開を置く。その小切開に第二の固定部材（２）を挿入する。引張りベルト（３）を引張り切開創を図２のように開創する。
次にコンバーター（６）を第一の固定部材（１）に気密に固定する。コンバーター（６）の気密部材（７）よりトロッカー等を刺入し、そこから腹腔鏡、処置具を挿入して大腸の剥離、リンパ節の郭清、血管の処理などの処置を腹腔鏡下で行い、十分な受動ができた後、コンバーター（６）を取り外して大腸を体外へ取り出し、直視下で患部付近の大腸の切離・縫合等を行った後、体内へ大腸を戻す。再度、コンバーター（６）を第一の固定部材（１）に取り付け、再気腹を行い、腹腔内を十分に観察する。再度、処置が必要な場合は気腹下で処置を行うか、気腹を落とし、コンバーター（６）を取り外して処置を行う。処置中に引張りベルトの解除が必要になった場合には解除手段を使用して解除する。
【００３４】
【発明の効果】
本発明の医療用処置用具は、コンバーター（６）の取り外しのみで簡単に気腹下での処置と腹腔外処置との切り替えができる。コンバーター（６）には気密部材（７）が付設されているために気腹下での処置を行う場合には本発明品からもトロッカーを挿入しての鉗子操作が行える。筒状部材（５）により癌部位の摘出の際に腹壁の切開創が保護され、癌細胞の創感染の問題がない。引張りベルト（３）のラチェット機構により切開創に十分な張力を与えた状態で固定でき、開創の程度が小さくなることはない。また、解除が必要な場合は、係止めを解除する手段を使用して引張りベルトを解除することもできる。
腹腔鏡下手術の術中には、簡単に気腹下処置と腹腔外処置との切り替えができ、直視下における創部直下の処置が容易である為、術者のストレスが軽減され、手術時間のスピードアップが図られ、更には、開腹手術より手術創が小さく患者への負担が軽いために、患者の術後入院期間も短くなり、患者、病院にとって大きなメリットがある。更に、術後の切開跡は目立たない程小さく、美容上有効である。
【図面の簡単な説明】
【図１】本発明の一実施例の医療用処置用具を示し、（Ａ）はその外観図を示す斜視図、（Ｂ）はコンバーターおよび気密部材の断面図、および（Ｃ）は筒状部材の断面図である。
【図２】本発明による医療用処置用具を創部に留置した状態の一例を示す概略図。
【図３】本発明による医療用処置用具の引張りベルトの実施例を示し、（Ａ）はその一実施例、（Ｂ）は他の実施例の斜視図、および（Ｃ）はさらに他の実施例の斜視図である。
【図４】図３に示す引張りベルトにおけるラチェット溝を示し、（Ａ）はその一実施例の断面図、および（Ｂ）はその他の実施例の断面図である。
【図５】ベルト抵抗調整部材の一実施例を示し、（Ａ）はその斜視図、および（Ｂ）は切断面図である。
【図６】ベルト抵抗調整部材における薄板を使用した係り止め状態の解除を示し、（Ａ）は第一の固定部材との関係を示す斜視図、（Ｂ）はベルト抵抗調整部材への挿入前の状態を示す断面図、および（Ｃ）は挿入した状態の断面図である。
【図７】ベルト抵抗調整部材の他の実施例を示し、（Ａ）はその斜視図、（Ｂ）は引張りベルトを挿入した状態の断面図、および（Ｃ）は引張りベルトの離脱状態を示す断面図である。
【図８】ベルト抵抗調整部材のさらに他の実施例を示す斜視図である。
【図９】ベルト抵抗調整部材のもう一つの他の実施例を示し、（Ａ）は引張りベルトが係合状態における断面図、（Ｂ）は（Ａ）の図面直角方向の断面図、（Ｃ）は引張りベルトの離脱状態の断面図、および（Ｄ）は（Ｃ）の図面直角方向の断面図である。
【図１０】二部品からなるベルト抵抗調整部材のさらにもう一つの他の一実施例を示し、（Ａ）は一体にされた状態を示す斜視図、および（Ｂ）は分離された状態を示す斜視図である。
【図１１】三つの部品からなるベルト抵抗調整部材のその上のさらにもう一つの他の実施例を示し、（Ａ）はその斜視図、（Ｂ）は係合状態を示すその平面図、および（Ｃ）は離脱状態を示すその平面図である。
【図１２】コンバーターの一実施例を示す断面図である。
【図１３】コンバーターの他の実施例を示す断面図である。
【図１４】コンバーターのさらに他の実施例を示す断面図である。
【符号の説明】
１第一の固定部材
２第二の固定部材
３引張りベルト
４ベルト抵抗調整部材
５筒状部材
６コンバーター
７気密部材
８第一の気密部材
９第二の気密部材
１０窓
１１ツメ
１２開口部
１３体表設置面
１４リブ
１５腹腔内
１６体表面
１７ラチェット溝
１８スリット
１９凹凸
２０薄板
２１突起部
２２切り欠き部
２３バネ
２４凹凸操作部[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a medical treatment tool for opening an incision. In particular, in endoscopic surgery, after the treatment under the pneumoperitoneum, the pneumoperitoneum is released and the organ is taken out of the body for treatment, or the organ is returned to the body again and the affected part is operated under the pneumoperitoneum. It is related with the medical treatment tool for performing confirmation of this and additional treatment.
[0002]
[Prior art]
In recent years, endoscopic surgery has been widely practiced as a method of minimally invasive surgery. Endoscopic surgery is less invasive, has advantages such as a shorter hospital stay and less trauma. On the other hand, since the surgeon performs the operation by operating a plurality of forceps and other treatment tools while viewing the image projected on the endoscope on the screen, the operation is difficult and takes a long time, and it is difficult to feel a lot of stress. . In particular, surgery on the stomach and large intestine often takes a long time, and the surgeon is subjected to great stress. For this reason, when it is assumed that a large specimen will eventually be removed after the endoscopic procedure, it is assumed that a small incision will be made, and the organ is drawn from the small incision to the body surface under the pneumoperitoneum. There is a need for a medical treatment tool that can easily close a notch opening so that the treatment to be performed can be easily transferred.
[0003]
In Japanese Patent Application Laid-Open No. 11-160942, a device comprising a member that is fixed with the abdominal wall sandwiched between it and a cylindrical member, the interval between the members that sandwich the abdominal wall is pulled up with a thread or the like that is previously fixed to a fixing member inserted into the abdominal cavity. With a simple mechanism that adjusts to the fixing member outside, and two types of airtight members to keep the airtightness when the treatment tool is not inserted and when it is inserted, forceps can be inserted through the slit opening during re-gassing. -A medical treatment instrument that can be operated is disclosed.
By using this device, treatment such as exfoliation around the excised organ is sufficiently performed under the pneumoperitoneum, then a small incision of about 3 to 5 cm is made at the place where the organ is removed, and the target organ is removed from the incision opening. It can be taken out of the body and the surgeon can directly see the excision, excision, and suturing of the lesion, and perform the operation. However, “When the incision is opened with the thread, the thread is caught in the abdominal wall of the incision and it is difficult to perform the sufficient opening.” “In addition to the protrusions for fixing the fixing member interval adjustment sheet, the almost sheet is the opening. There is a problem that it is difficult to perform the treatment by pulling out the organ.
[0004]
Japanese Patent Application Laid-Open No. 10-108868 discloses a valve and a trocar mantle with valve that can prevent the insufflation of pneumoperitoneum gas from the abdominal cavity regardless of the type of forceps used. This valve attaches a flexible cylindrical member between two rings, twists the two rings in opposite directions, inserts forceps with different outer diameters, and the operator's arm to perform treatment in the body It is possible to take the organ out of the body by opening this valve and perform the treatment. However, this method has a drawback that it is difficult to move forward and backward because forceps and the like are fixed while being squeezed by a valve. In addition, when the arm is inserted, the thickness of the arm changes depending on the back and forth movement, so that it becomes difficult to maintain the airtightness in some cases, and it is necessary to adjust the throttle of the valve. Furthermore, since the fixing force of the device to the abdominal wall depends only on the rubber elasticity of the cylindrical member, there is a problem that the wound cannot be sufficiently opened because the thickness of the abdominal wall cannot be flexibly handled.
[0005]
US Pat. No. 5,480,410 is a flexible enclosure with an inner surface and an open end, the open end has a deployment means for protecting the abdominal wall and airtight, and has at least one access opening for accessing the interior of the enclosure, An apparatus is disclosed that is capable of performing a surgical operation within an enclosure. This device is not a rigid trocar used in conventional laparoscopic and thoracoscopic surgery, but is made of a flexible sheet material. It is inserted from the mouth and deployed in the abdominal cavity. Carbon dioxide gas for abdominal stomach flows into the enclosure from the abdominal cavity to expand the enclosure, and the deployment means protects the abdominal wall from airtightness. Furthermore, if a plurality of access openings are attached to the outer peripheral surface of the enclosure, a plurality of forceps can be inserted, observation directly under the wound is possible, and the wound edge is protected. However, since the enclosure is basically spherical and the distance to each access opening attached to the outer peripheral surface is determined and fixed at the time of setting, when inserting a plurality of treatment instruments, When the treatment tool is moved greatly, other treatment tools are also dragged and moved, and the incision in the abdominal wall is large relative to the treatment tool such as forceps, and there is no fulcrum on the abdominal wall during operation. In addition, there is a problem that sufficient wound cannot be obtained depending on the thickness of the abdominal wall because the wound is relied only on the stretching force of the sheet.
[0006]
US Pat. No. 5,640,977 discloses a device that has a structure having an outer sleeve and two sealing means, enters the abdominal cavity through a small opening, and forms an airtight space in the outer sleeve using the two sealing means. This device is able to treat internal organs in a puffy state when the operator's hand and arm are inserted into the body through the device, and if the third sealing means is used, the arm is removed. Even in the state, the sleeve and the inside of the body can be kept airtight. However, this device has a structure in which the sleeve part is bonded to the drape on the patient's body surface when the surgeon wants to pull out the internal organ from the body and treat the upper part from the bonded part. Therefore, the drape is cut out and the whole device is taken out once or the sleeve part is not cut out, and the organ cannot be taken out from the body and treated. If the device is taken out, cancer tissue or the like may adhere to the abdominal wall, and if the sleeve portion is cut off, the pneumoperitoneum is performed again after the treatment outside the body, and observation and treatment cannot be performed in the abdominal cavity.
[0007]
US Pat. No. 5,813,409 discloses a device for separating the sleeve and the abdominal wall fixing part and snapping and fixing the ring at the distal end of the sleeve and the ring of the abdominal wall fixing part. Since this device can separate the sleeve and the abdominal wall fixing part, the sleeve part can be removed, the internal organs can be pulled out of the body while leaving the abdominal wall fixing part on the abdominal wall, and cancer tissue does not adhere to the incision After the treatment is completed, the organ can be returned to the body, the sleeve can be fixed again, and observation and treatment can be performed under the pneumoperitoneum. However, it is difficult to snap the sleeve and the abdominal wall fixing ring over the entire circumference with a snap, and if there is an insufficiently fitted portion, the airtightness cannot be maintained. Also, if the treatment tool is operated through the sleeve, this device also has the disadvantage that the incision in the abdominal wall is larger than the treatment tool such as forceps, and there is no fulcrum on the abdominal wall at the time of operation, so that the forceps operation becomes complicated. It was.
[0008]
US Pat. No. 5,366,478 and Special Table 2000-501978 disclose a device for inflating a donut-shaped balloon connected to the inside and outside of the body so as to close the lumen and maintain airtightness in the abdominal cavity when inserting or removing a hand or forceps. . Since this device has a simple structure and is easy to assemble, the operation time can be shortened. However, in the device of USP 5366478, when the pneumothorax is released and the organ is taken out of the body for treatment, the balloon must be deflated, and at the same time the wound is closed, so a new retracting device must be used. There was a disadvantage of not becoming. In both cases, since the balloon inflates in the circumferential direction, the height of the device from the body surface becomes high, and it is difficult to sufficiently pull out the organ from the body, and it is difficult to place forceps or the like on the treatment site. It was.
[0009]
In JP-A-11-99156, a sleeve is fixed from above and below the abdominal wall with a ring-shaped member, and has two valves: a normal seal valve and a valve having a slit-like opening made of an elastic thin film. An apparatus having improved airtightness during insertion and non-insertion is disclosed. This device maintains airtightness by expanding the slit-shaped valve so that the contact surfaces consisting of the folded parts are pressed against each other by the abdominal pressure when the hand and forceps are not inserted. Since no force greater than the elastic force of the elastic thin film is generated, the force for tightening the arm is very small, and the stress on the operator is reduced over a long period of use. However, this device has the disadvantage that the slit-shaped valve gets in the way, especially when you want to perform treatment by removing the pneumoperitonec and taking the organ out of the body or directly under the wound. Further, when the treatment tool is operated through the sleeve, this device also has a disadvantage that the incision in the abdominal wall is larger than the treatment tool such as forceps, and there is no fulcrum on the abdominal wall at the time of operation, so that the forceps operation becomes complicated. .
[0010]
In US Pat. No. 5,741,298, a port that is firmly clamped from the outside and inside of the abdominal wall incision peripheral part and a lid attached to the port is used to close the lumen to maintain airtightness in the abdominal cavity when inserting or removing a hand or forceps An apparatus is disclosed. Since this device has a simple structure and is easy to assemble, the operation time can be shortened. However, this device has a drawback in that it cannot flexibly cope with the size of the incision and the thickness of the abdominal wall, and a sufficient wound opening cannot be obtained.
[0011]
US Pat. No. 5,653,705 discloses a device that maintains a hermetic abdominal cavity when inserting or removing a hand or forceps by attaching a threaded taper-shaped annular member to the abdominal wall and fixing it, attaching a removable flexible envelope. Has been. In this device, an access port to the abdominal cavity can be easily installed just by screwing the annular member into the wound, and the annular member can be a fulcrum of the forceps, so that the forceps can be easily operated. However, since the annular member is screwed into the wound part and used, there is a risk of damaging the wound part, and in order to make an angle that is easy to screw in, the problem that the annular member becomes bulky, the thickness of the abdominal wall and the size of the incision However, there is a drawback that it cannot respond flexibly.
[0012]
[Problems to be solved by the invention]
The present invention solves such drawbacks of conventional endoscopic surgery, and the purpose of the present invention is to enable flexible installation corresponding to various abdominal wall thicknesses and incision sizes. In order to facilitate the treatment around the incision wound, secondary retraction operation after installation is possible, the height from the body surface of the instrument at the time of installation is low, and easy subpneumotomy and extra-abdominal treatment An object of the present invention is to provide a medical treatment tool that can be switched to a treatment and can perform a forceps operation when performing a treatment under a pneumoperitoneum.
[0013]
[Means for Solving the Problems]
That is, the present invention
(1) A medical treatment in which a first fixing member is attached to the opening on the proximal end side of the tubular member, and the second fixing member is attached to the opening on the distal end side. In the ingredients
Two or more tension belts for adjusting the length between the two fixing members are attached to the second fixing member, and the tension belt is disposed on a side surface perpendicular to the body surface ground surface of the first fixing member. belt resistance-adjusting member having means for latching hermetically is attached to said tension belt is disposed through the side surface and said belt resistance-adjusting member of the first fixing member in the horizontal direction, the first A medical treatment instrument having a converter that is installed on the fixing member of the first fixing member and that is engaged with the outer edge of the first fixing member and is hermetically fixed to the first fixing member;
(2) The means for airtightly locking the tension belt is unevenness formed in the vicinity of the slit through which the tension belt of the belt resistance adjusting member passes, and the tension belt corresponds to the unevenness, and the unevenness The medical treatment tool according to (1), wherein a ratchet groove that is locked to the medical device is formed,
(3) The medical treatment tool according to (2), wherein the unevenness of the belt resistance adjusting member has a sawtooth shape,
(4) The medical treatment tool according to (2) or (3), comprising means for releasing the engagement between the unevenness of the belt resistance adjusting member and the ratchet groove of the tension belt,
(5) The medical treatment tool according to (4), wherein the means for releasing the engagement is a thin plate inserted between the ratchet groove of the tension belt and the unevenness of the belt resistance adjusting member,
(6) The medical treatment tool according to (4), wherein the means for releasing the locking is a protrusion that is connected to the unevenness of the belt resistance adjusting member and protrudes from the belt resistance adjusting member.
(7) The medical device according to any one of (1) to (6), wherein at least a part of both or one of the belt resistance adjusting member and the tension belt is made of a material having a longitudinal elastic modulus of 0.05 to 10 kg / mm ^2. Treatment tool.
[0014]
DETAILED DESCRIPTION OF THE INVENTION
The medical treatment tool of the present invention will be described with reference to the drawings. FIG. 1 shows the overall appearance. The medical treatment tool of the present invention comprises the following parts. The first fixing member (1), the second fixing member (2), the tension belt (3), the belt resistance adjusting member (4), the cylindrical member (5), the converter (6) and the airtight member (7). It is.
[0015]
(Structure of medical treatment device)
Briefly describing the structure, the second fixing member (2) has an opening (12) for organ removal, and is fixed along the opening (12) of the tubular member (5). The other end of the cylindrical member (5) is connected to the first fixing member (1). An arbitrary number of tension belts (3) are attached to the second fixing member (2). The tension belt (3) is disposed through the slit (18) of the belt resistance adjusting member (4). The belt resistance adjusting member (4) is disposed on the first fixing member (1). The first fixing member (1) is provided with a converter (6) for preventing inhalation of insufflation gas. An airtight member (7) is attached to the converter (6) substantially at the center. The tubular member (5) and the tension belt (3) are longer than the thickness of the abdominal wall and can be installed at any thickness of the abdominal wall. Creation is possible. Since the converter (6) can be easily attached to the first fixing member (1), the transition between the pneumoperitoneum operation and the operation after taking out the organ is simple. Since the airtight member (7) is attached to the converter (6), a trocar or the like can be installed, and treatment using forceps or the like is possible.
[0016]
(First fixing member)
The first fixing member (1) is attached along the opening (12) of the tubular member (5). Usually, it is produced by injection molding or compression molding. It is fixed to the surface of the tubular member (5) by heat welding or adhesive fixing, or by physical tightening using an O-ring or the like. The shape is circular or polygonal and has a shape with an opening for organ removal (12) in the center. There is no particular limitation, but when the operator's fist can be inserted into the opening (12) and placed on the abdomen It is preferable that the ring is not bulky, and a ring shape having an outer dimension of 50 to 300 mm in diameter and an inner dimension of 30 to 280 mm is preferable. The lower the height of the first fixing member (1), the easier it is to draw the organ from the opening (12) of the first fixing member (1) to the body surface, and the opening (12) as a fulcrum. When a treatment tool having a long handle is inserted into the body, the treatment range is widened, preferably 5 to 50 mm.
[0017]
A belt resistance adjusting member (4) is disposed on the first fixing member (1). The belt resistance adjusting member (4) may be disposed in the body surface ground surface (13) of the first fixing member (1) or in a groove dug down from the opposite side, but as shown in FIG. It is better to place a gap on the side surface perpendicular to the body surface ground plane (13) of one fixing member (1) and place the belt adjustment member (4) in this gap. A single member can be seamless, and it is easy to ensure airtightness, which is desirable. In addition, it is desirable to install a rib at a portion where the belt resistance adjusting member (4) is fixed because airtightness is improved.
[0018]
The belt resistance adjusting member is constructed so that the tension belt (3) is pulled horizontally in the first fixing member (1) so that the tension belt (3) does not interfere with the treatment of pulling out the organ. It is desirable to attach (4). The converter (6) is fitted to the first fixing member (1). It is desirable that the outer edge of the first fixing member (1) has a shape that the pawl of the converter (6) is caught so that the converter (6) can be easily fitted. The upper part of the first fixing member (1) is desirably flat so as not to be damaged because the pulled-out organ is in direct contact. The first fixing member (1) is made of a material such as vinyl chloride resin, polyurethane resin, polyamide resin, polyethylene resin, polypropylene resin, polyacetal resin, ABS resin, SEBS resin, silicone rubber, or stainless steel. .
[0019]
(Second fixing member)
The second fixing member (2) is attached along the opening of the cylindrical member (5). Usually it is made by injection molding, compression molding or extrusion tube processing. It is wrapped in a cylindrical member (5) and is in close contact and thermally welded or adhesively fixed, or is in close contact with the surface of the second fixing member (2) and thermally welded or adhesively fixed. Alternatively, it may be fixed by physical tightening using an O-ring or the like. When performing laparoscopic-assisted colorectal resection, it is preferable to set an inner diameter of about 30 to 120 mm and an outer diameter of about 40 to 200 mm for a small incision of about 20 to 80 mm. Since the thickness is required not to be bulky in the abdominal cavity, about 0.5 to 10 mm is preferable. Since the second fixing member (2) is folded and inserted into the abdominal cavity from the incision, it is preferable that the material has a certain degree of elasticity. The material of the second fixing member (2) is a vinyl chloride resin, polyurethane resin, polyamide resin, polyethylene resin, polypropylene resin, polyacetal resin, ABS resin, SEBS resin, silicone rubber, or a metal such as stainless steel. .
[0020]
(Tension belt)
The tension belt (3) is connected to the second fixing member (2) and is disposed so as to pass the slit (18) of the belt resistance adjusting member (4). The width of the tension belt (3) is desirably 10 mm or more in order to open the incision large (as much as possible in a circle) as shown in FIG. 2, but if it is too wide, it is difficult to insert into the incision. It is preferable that it is the range of 10-60 mm. The thickness is preferably a sheet of 0.1 to 5 mm in order to keep the height of the tool on the body surface low. The length of the tension belt (3) should be long to accommodate various abdominal walls, but if it is too long, it will be exposed to the body surface when it is opened, and the puncture site such as a trocar will be limited. The thickness is preferably 30 to 200 mm.
[0021]
It is desirable that the tension belt (3) is provided with a saw-toothed ratchet groove (17) as shown in FIG. 3 so that the size of the incision wound does not shrink. The depth of the ratchet groove (17) is preferably designed to be about 0.5 to 2.5 mm in order to keep the thickness thin. The ratchet groove (17) may be partly provided as shown in FIGS. As shown in FIG. 4, when the angle A of the ratchet groove (17) is an acute shape, the resistance at the time of opening is preferably reduced. The ratchet groove (17) attached to the tension belt (3) may be attached to the side surface. However, as shown in FIG. 1, the ratchet groove on the side opposite to the opening (12) is used to pull out the organ. Since it does not contact the groove (17), there is no fear of damaging the organ, which is preferable.
[0022]
The material is moderately flexible and good for sliding. In order to perform a smooth operation, the tension belt (3) preferably has an appropriate hardness (a material having a Shore hardness of A40 to D60) so that the whole or a part of the tension belt or the like is deformed. Although it is produced by nonwoven fabric or a sheet material of woven fabric, extrusion molding, injection molding, compression molding or the like, it is not particularly limited. Polyamide resin, vinyl chloride resin, polyurethane resin, polyethylene resin, polypropylene resin, polyacetal resin and the like can be used. A sheet containing a resin or a metal mesh is also preferable because of less deformation.
[0023]
(Belt resistance adjustment member)
The belt resistance adjusting member (4) is attached to the first fixing member (1). The belt resistance adjusting member (4) is provided with a slit (18) for passing the tension belt (3). In order to ensure airtightness, it is preferable that the slit (18) has substantially the same shape as the cross section of the tension belt. Around the slit, an unevenness (19) corresponding to the ratchet groove (17) of the tension belt (3) is attached, and is engaged with the tension belt (3) to prevent the retracted state from contracting. It is desirable that the belt resistance adjusting member (4) is provided with a rib (14) or a concave portion so as to keep airtightness when arranged on the first fixing member (1). An example is shown in FIG.
[0024]
The belt resistance adjusting member (4) is preferably provided with means capable of releasing the locked state of the tension belt (3) so that the retracted state and the contracted state can be switched flexibly. For example, as shown in FIG. 6, the locking of the unevenness (19) can be released by inserting the thin plate (20) between the unevenness (19) of the tension belt (3) and the belt resistance adjusting member (4). . The thin plate (20) may be provided as another member, or the thin plate (20) may be slidably fixed to the first fixing member (1).
[0025]
Further, as shown in FIGS. 7 and 8, a protrusion (21) extending from the unevenness (19) is attached so that the unevenness of the belt resistance adjusting member (4) can be moved in a direction that can be released from the locked state. The unevenness (19) may be moved by operating this. As shown in FIG. 7, the belt resistance adjusting member (4) is provided with notches (22) near both ends of the unevenness (19) so that the unevenness (19) can be moved reliably. Is desirable. FIG. 8 is composed of two parts, and when the projection (21) of the part including the unevenness (19) is pulled, it moves downward according to a guide attached to the remaining part. The locked state is released by moving the part including the unevenness (19) on the lower side.
[0026]
As shown in FIG. 9, the belt resistance adjusting member (4) is divided into two parts (4A, 4B), a spring is attached to the lower side of the part (4B) including the unevenness (19), and the unevenness (19) is moved up and down. It may be possible to move to. Further, as shown in FIG. 10, the belt resistance adjusting member (4) may be composed of two parts (4A, 4B), and the unevenness (19) may be pulled out in the horizontal direction. As shown in FIG. 11, the belt resistance adjusting member (4) may be divided into three parts, and the unevenness (19) may be opened and moved by the unevenness operating portion (24). Alternatively, the belt resistance adjusting member (4) may be hollowed to release the locking by reducing the pressure.
[0027]
Since the belt resistance adjusting member (4) is provided with irregularities (19) so as to suppress the reduction of the degree of opening of the incision layer, resistance is generated during the opening operation. In order to perform a smooth operation, the belt resistance adjusting member (4) preferably has an appropriate hardness (a material having a Shore hardness of A40 to D60) so as to deform the whole or a part of the unevenness (19). As the material, vinyl chloride resin, polyurethane resin, polyamide resin, polyethylene resin, polypropylene resin, polyacetal resin, ABS resin, SEBS resin, and silicone rubber are used.
[0028]
(Cylindrical member)
The tubular member (5) is a flat or tapered tubular shape having a thickness of 0.05 to 3 mm, and is usually produced by extrusion molding or inflation molding, but is not particularly limited. The size of the tubular member (5) varies depending on the site to be treated and the purpose, but when used for laparoscopic-assisted colorectal resection, the outer diameter is preferably 30 to 300 mm. When using, treatment tools such as endoscopes and forceps frequently come in and out, so it is better to choose a material that is not bulky and reasonably flexible, and that does not easily break or tear even when the treatment tool hits it. Materials such as soft vinyl chloride resin, polyurethane resin, polyethylene resin, polyamide resin, polypropylene resin, polyester resin, SEBS resin, silicone rubber, and natural rubber are preferable.
[0029]
(converter)
The converter (6) is installed on the first fixing member (1) to ensure airtightness in the abdominal cavity during pneumoperitoneum. When attaching and detaching, the first fixing member (1) may be fixed by unevenness or screws, but a claw (11) is attached to the end of the converter (6), and the first fixing member (1) It is more convenient and preferable to adopt a mode of fitting to the side surface. Usually formed by injection molding, compression molding or the like. The converter (6) is provided with an airtight member (7) having no opening as shown in FIGS. 1 (B) and 12, and the first airtight member (8) as shown in FIG. And a type in which a second airtight member (9) is attached, and a type in which the first airtight member (8) and the second airtight member (9) are integrally formed as shown in FIG. An airtight member (7) is attached to the converter (6), and a window (10) is formed in the center thereof. The size of the window (10) is determined by the size of the treatment instrument to be inserted, and it is appropriate to set the diameter to 1 to 250 mm, preferably 1 to 150 mm. The height is suitably 1 to 40 mm so as not to disturb the treatment. As the material, a hard resin such as vinyl chloride resin, polyurethane resin, polyethylene resin, polypropylene resin, polyacetal resin, polycarbonate resin, polysulfone resin, or synthetic rubber such as silicone rubber, natural rubber, NBR, or the like is used.
[0030]
(Airtight member)
The hermetic member (7) is arranged to keep hermetic when inserting the trocar or forceps as shown in FIG. A diaphragm without an opening. The thickness is preferably 0.1 to 3 mm. This is because if it is less than 0.1 mm, the valve is easily deformed by the pressure of carbon dioxide gas, and if it exceeds 3 mm, the frictional resistance when inserting a treatment instrument such as forceps increases, making insertion difficult. The inner diameter is preferably 0.5 mm to 80 mm in accordance with the outer diameter of the treatment instrument or the like. The material of the airtight member preferably has a tear strength of 5 to 100 N / mm so that the airtightness can be maintained when a treatment instrument such as a trocar is inserted. Further, those having flexibility are more preferable, for example, natural rubber, silicone rubber, vinyl chloride resin, urethane resin, SEBS resin and the like are preferable.
[0031]
(First airtight member)
The first airtight member (8) is installed in order to keep airtightness when forceps or the like are not inserted, and the distal end of the proximal end is closed with a cap or the like, or a flap type is formed inside as shown in FIG. A valve member such as a valve or a duckbill type valve may be provided. Further, the type shown in FIG. 14 in which a slit is simply added to the sheet may be used. What is necessary is just to set the length of a slit according to the size of the trocar to be inserted, a treatment tool, or an arm, and 1-250 mm, especially 1-150 mm are preferable. In the case of integral molding as shown in FIG. 14, it is desirable to install a thick portion so that the second airtight member is not torn even when the slit is torn. In the case of closing with a cap or the like, a fitting member may be attached to the proximal end inlet, and fitted with irregularities therewith, or may be fixed with screws. Caps are usually molded by injection molding, etc. The material is a slightly hard resin such as vinyl chloride resin, polyurethane resin, polyethylene resin, polypropylene resin, polyacetal resin, polycarbonate resin, polysulfone resin, or synthetic rubber such as silicone rubber, natural rubber, NBR, etc. Rubber or the like is used. A flap-type valve is usually formed of an elastic member such as silicone rubber into a flap shape, even if it is a combination of a hard molded product built in a trocar used in laparoscopic surgery or the like and a spring member. You may process and use. Since the flap type valve does not open to the outside of the body and moves only to the inside of the body, the flap is pushed and closed by the positive pressure inside the body when the treatment tool or the like is not inserted. The flap type valve is molded by injection molding, compression molding, or the like, and its material is vinyl chloride resin, polyurethane resin, polyethylene resin, polypropylene resin, polyacetal resin, polycarbonate resin, polysulfone resin, silicone rubber, or the like. Similarly, duckbill type valves are molded by injection molding or compression molding, and are mainly made of an elastic material such as silicone rubber.
[0032]
(Second airtight member)
The second hermetic member (9) is arranged to keep hermeticity when inserting forceps or the like, and may be provided with a seal valve or the like having a circular hole. The seal valve is manufactured by injection molding, compression molding, sheet processing or the like, and is thermally welded or bonded to the proximal end inlet or the converter (6). The thickness of the seal valve is preferably about 0.1 to 3 mm. This is because if it is less than 0.1 mm, the valve is easily deformed by the pressure of carbon dioxide gas, and if it exceeds 3 mm, the frictional resistance when inserting a treatment instrument such as forceps increases, making insertion difficult. The inner diameter is suitably 0.5 mm to 30 mm according to the outer diameter of the treatment instrument or the like. The material of the seal valve is preferably flexible, and for example, natural rubber, silicone rubber, vinyl chloride resin, urethane resin, SEBS resin and the like are suitable.
[0033]
(how to use)
Next, an actual method of using the medical treatment tool according to the present invention will be described. When performing laparoscopic-assisted colorectal resection, first, a plurality of trocars are inserted into the abdomen, and a small incision of about 3 to 5 cm is placed at the expected site of organ removal. The second fixing member (2) is inserted into the small incision. The tension belt (3) is pulled to open the incision as shown in FIG.
Next, the converter (6) is airtightly fixed to the first fixing member (1). A trocar or the like is inserted from the airtight member (7) of the converter (6), and a laparoscope and a treatment tool are inserted from there to perform procedures such as detachment of the large intestine, lymph node dissection, and blood vessel treatment under the laparoscope. After sufficient passiveness is obtained, the converter (6) is removed and the large intestine is taken out of the body, and the large intestine in the vicinity of the affected part is cut and sutured under direct vision, and then the large intestine is returned to the body. Again, the converter (6) is attached to the first fixing member (1), re-inferiorated, and the inside of the abdominal cavity is sufficiently observed. If treatment is necessary again, treatment is performed under pneumoperitoneum or pneumoperitoneum is dropped, and the converter (6) is removed and treatment is performed. If the tension belt needs to be released during the procedure, it is released using the release means.
[0034]
【The invention's effect】
The medical treatment tool of the present invention can be easily switched between the treatment under the pneumoperitoneum and the extraabdominal treatment simply by removing the converter (6). Since the airtight member (7) is attached to the converter (6), the forceps operation by inserting the trocar from the present invention can be performed when performing the treatment under the stomach. The tubular member (5) protects the incision of the abdominal wall when the cancer site is removed, and there is no problem of wound infection of cancer cells. The ratchet mechanism of the tension belt (3) can be fixed in a state where a sufficient tension is applied to the incision, and the degree of opening is not reduced. If the release is necessary, the tension belt can be released by using a means for releasing the latch.
During laparoscopic surgery, it is easy to switch between pneumothorax and extra-abdominal procedures, and the treatment directly under the wound is easy under direct vision, reducing the stress on the operator and speeding up the operation time. Furthermore, since the surgical wound is smaller than the laparotomy and the burden on the patient is lighter, the postoperative hospitalization period of the patient is shortened, which is a great advantage for the patient and the hospital. Furthermore, the post-operative incision mark is inconspicuously small and is cosmetically effective.
[Brief description of the drawings]
1A and 1B show a medical treatment tool according to an embodiment of the present invention, in which FIG. 1A is a perspective view showing an external view thereof, FIG. 1B is a sectional view of a converter and an airtight member, and FIG. FIG.
FIG. 2 is a schematic view showing an example of a state in which a medical treatment tool according to the present invention is placed in a wound part.
FIGS. 3A and 3B show an embodiment of a tension belt of a medical treatment tool according to the present invention, FIG. 3A is one embodiment thereof, FIG. 3B is a perspective view of another embodiment, and FIG. It is a perspective view of an example.
4 shows a ratchet groove in the tension belt shown in FIG. 3, (A) is a cross-sectional view of one embodiment, and (B) is a cross-sectional view of another embodiment.
FIGS. 5A and 5B show an embodiment of a belt resistance adjusting member, in which FIG. 5A is a perspective view thereof, and FIG.
FIGS. 6A and 6B show the release of the locked state using a thin plate in the belt resistance adjusting member, FIG. 6A is a perspective view showing the relationship with the first fixing member, and FIG. 6B shows the state before insertion into the belt resistance adjusting member; Sectional drawing which shows the state of (2), and (C) are sectional drawings of the state inserted.
7A and 7B show another embodiment of the belt resistance adjusting member, in which FIG. 7A is a perspective view thereof, FIG. 7B is a sectional view of a state in which a tension belt is inserted, and FIG. It is sectional drawing.
FIG. 8 is a perspective view showing still another embodiment of the belt resistance adjusting member.
9A and 9B show another embodiment of the belt resistance adjusting member, wherein FIG. 9A is a cross-sectional view of the tension belt in an engaged state, FIG. 9B is a cross-sectional view of FIG. ) Is a sectional view of the tension belt in a detached state, and (D) is a sectional view in the direction perpendicular to the drawing of (C).
FIGS. 10A and 10B show still another embodiment of a belt resistance adjusting member made of two parts, FIG. 10A is a perspective view showing an integrated state, and FIG. 10B is a separated state. FIGS. It is a perspective view.
11A and 11B show still another embodiment of the belt resistance adjusting member comprising three parts, wherein FIG. 11A is a perspective view thereof, FIG. 11B is a plan view showing an engaged state thereof, and FIG. (C) is the top view which shows a detachment | leave state.
FIG. 12 is a cross-sectional view showing an embodiment of a converter.
FIG. 13 is a cross-sectional view showing another embodiment of the converter.
FIG. 14 is a cross-sectional view showing still another embodiment of the converter.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 1st fixing member 2 2nd fixing member 3 Pull belt 4 Belt resistance adjustment member 5 Cylindrical member 6 Converter 7 Airtight member 8 First airtight member 9 Second airtight member 10 Window 11 Claw 12 Opening 13 Body Front mounting surface 14 Rib 15 Intra-abdominal 16 Body surface 17 Ratchet groove 18 Slit 19 Concavity and convexity 20 Thin plate 21 Projection portion 22 Notch portion 23 Spring 24 Concavity and convexity operation portion

Claims

In the medical treatment instrument placed in the incision where the first fixing member is attached to the opening on the proximal end side of the cylindrical member and the second fixing member is attached to the opening on the distal end side,
Two or more tension belts for adjusting the length between the two fixing members are attached to the second fixing member, and the tension belt is disposed on a side surface perpendicular to the body surface ground surface of the first fixing member. A belt resistance adjusting member having means for locking the airtightly is attached,
The tensioning belt is disposed through the side surface and said belt resistance-adjusting member of the first fixing member in the horizontal direction,
A medical device comprising a converter installed on the first fixing member, the outer edge engaging with the outer edge of the first fixing member, and hermetically fixed to the first fixing member. Treatment tool.

The means for airtightly locking the tension belt is unevenness formed in the vicinity of the slit through which the tension belt of the belt resistance adjusting member passes,
The medical treatment tool according to claim 1, wherein a ratchet groove is formed on the tension belt so as to correspond to the unevenness and to be locked to the unevenness.

The medical treatment tool according to claim 2, wherein the unevenness of the belt resistance adjusting member has a sawtooth shape.

The medical treatment tool according to claim 2 or 3, further comprising means for releasing engagement between the unevenness of the belt resistance adjusting member and the ratchet groove of the tension belt.

The medical treatment tool according to claim 4, wherein the means for releasing the locking is a thin plate inserted between the ratchet groove of the tension belt and the unevenness of the belt resistance adjusting member.

The medical treatment tool according to claim 4, wherein the means for releasing the locking is a protrusion connected to the concave and convex portions of the belt resistance adjusting member and protruding from the belt resistance adjusting member.

It said belt resistance-adjusting member, both or at least a portion of one of said tension belt, medical treatment tool according to any constituted claims 1-6 with a material of the longitudinal elastic modulus of 0.05 to 10 kg / mm ^2.